Multimodal Imaging of the Biomechanical Properties of Kidney Tumors: Feasibility, Inter-modality Correspondence and Diagnostic Value
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Measurement of the root mean square error (RMSE)
研究概览
简要总结
The goal of this innovative project is to evaluate the correspondence between several imaging modalities for characterizing the elasticity of healthy and pathological renal tissue which could help improve the realism of 3D prints used by urological surgeons and allow the identification of new, complementary imaging biomarkers. The main objective is to develop a predictive model of the biomechanical properties of normal and pathological kidney tissue, as assessed by the reference method (Magnetic Resonance (MR)-elastography).
详细描述
Medical imaging plays a key role in the diagnostic and therapeutic management of renal cell carcinomas. It can be used to confirm the presence of a tumor, localize it, suggest malignancy or even histological subtype, guide sampling, perform TNM staging, assist in surgical scheduling, monitor therapeutic efficacy in the event of systemic treatment, guide ablathermy procedures and look for relapses after curative treatments have ended. Imaging of kidney tumors relies on three complementary imaging modalities: ultrasound (US), Computed Tomography based on X-ray absorption (CT-scan) and magnetic resonance imaging (MRI). The most commonly performed examination remains the CT scan, which is used to print 3D models. However, the correlation between renal parenchyma densities and renal tumors (before and during the scan acquisition times after injection) and elasticity parameters measured by US and MRI has never been explored.
This trial aim to evaluate the correspondence between several imaging modalities for characterizing the elasticity of healthy and pathological kidney tissue. It will also improve the realism of 3D models used by surgeons, and identify new complementary imaging biomarkers.
To achieve this aim, 50 patients will undergo DWI -elastography (Diffusion Weigthed Imaging-elastography) and MR-elastography sequences, as well as an US before the surgery. After surgery, a fragment of the resected specimen will be used to perform mechanical tests to determine the real hardness of the tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years of age)
- •Scheduled for surgical management with nephrectomy for kidney tumor in the urology department of Bordeaux University Hospital
- •CT scan available or scheduled for surgery
- •Consent expressed for integration of the UroCCR database
- •Expressed consent for participation in the Rein 3D Print Mechanics study
- •Patients affiliated or benefiting from social security system
排除标准
- •- Pregnant or breast-feeding women
- •Contraindication to MRI (Magnetic Resonance Imaging)
- •Contraindication to injection of gadoline contrast agents
- •Biopsy performed within 15 days prior to MRI, CT and ultrasound scans (risk of artifactual alteration, via iatrogenic hemorrhagic changes, of the biomechanical properties of the renal tumor and parenchyma).
- •Presence of thoracolumbar arthrodesis material
- •Obese patient (body mass index ≥ 30 kg/m²)
- •Cystic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm
- •Necrotic renal tumors with solid component (corresponding to either parietal thickening or tumor bud) < 2 cm
- •Person under legal protection
- •Difficulty understanding and expressing in French
研究组 & 干预措施
Patient with kidney cancer surgery
the patients will have an additionnal MRI elastography and Ultrasound exams for the research. The exams will be performed between the inclusion of the patient and the day before the surgery.
Both exams are non-invasive, without radiation
干预措施: MR-elastography exam (Diagnostic Test)
Patient with kidney cancer surgery
the patients will have an additionnal MRI elastography and Ultrasound exams for the research. The exams will be performed between the inclusion of the patient and the day before the surgery.
Both exams are non-invasive, without radiation
干预措施: Ultrasound exam (Diagnostic Test)
结局指标
主要结局
Measurement of the root mean square error (RMSE)
时间窗: Between Day 0 and Month 4
The aim is to successfully predict μMRE from dCT-, dCT40s, dCT90s, dCT10min (naming μCT the scan model prediction) with the lowest possible error.
次要结局
- Measure of Spearman's rho(Between Day 0 and Month 4)
- Measure of the qualitative assessment(Between Day 0 and Month 4)
- Measure of the contrast(Between Day 0 and Month 4)
- Measure of the noise(Between Day 0 and Month 4)
- Identification of imaging faisability limiting factors(Between Day 0 and Month 4)
- Evaluation of imaging repetabiliy limiting factors(Between Day 0 and Month 4)
- identification of decorrelation situations and potential bias between biomechanical properties obtained by hardness measurements in the different imaging modalities(Between Day 0 and Month 4)
- Carry out associations between histological categorical variables and numerical elasticity variables(Between Day 0 and Month 4)
- Verification of correlation between actual hardness and hardness assessed by the various imaging methods, carried out directly on a fragment of the fresh surgical specimen(Between Day 0 and Month 4)
- Measure of the accuracy(Between Day 0 and Month 4)